4.3.3 Post-published evidence and reliance on a purported technical effect for inventive step ("plausibility")

Abstract

In T 1994/22 the respondent (patent proprietor) inter alia had relied on post-published data D32 and submitted that Form II (according to claim 1 of the main request) as claimed had an improved photostability over Form III (comparative).

The respondent relied on the statements made in T 116/18 as regards G 2/21 and submitted that referring to the provision of a novel crystal of compound A (selexipag) and to a pharmaceutical product of "high quality for which constant effect can always be shown and a form which is handled easily industrially", the skilled person would have understood that the effect of improved photostability was implied by or at least related to the technical problem initially suggested in the originally filed application. Therefore, requirement (i) [in T 116/18], as encompassed by the technical teaching, was met. Furthermore, the respondent claimed the skilled person would not have had any legitimate reason to doubt that the improved photostability could be achieved with the claimed polymorphic form of selexipag. Therefore, requirement (ii) [in T 116/18], as embodied by the same originally disclosed invention, was also met in the present case.

In line with T 116/18, the board in the present case acknowledged that the mere fact that photostability or improved photostability was not contained in terms of a positive verbal statement in the application as filed and that the application as filed did not contain any data as regards photostability, as such, did not imply that the effect of improved photostability could not be relied on in terms of G 2/21 or T 116/18.

However, the board did not consider such a sweeping statement regarding "high quality" and "easy industrial handleability", which covers a plethora of potential advantageous properties, to encompass photostability, let alone improved photostability. If such a sweeping statement were sufficient, a reference to high quality would be sufficient to invoke whatever technical effect as being encompassed by an application as filed in the sense of G 2/21. This would essentially render the first criterion of order no. 2 of G 2/21 meaningless. In the present case, the application as filed was in fact directed to particle size, residual solvent content and amount of impurities, properties which are entirely unrelated to photostability. Therefore, based on these properties, having the common general knowledge in mind, the skilled person would by no means have recognised that (improved) photostability was relevant to the claimed subject-matter. Going from these specific properties to the effect of photostability would also clearly change the nature of the invention, contrary to what is required by T 116/18. Hence, the board found the effect of photostability was not encompassed by the teaching of the application as filed.

Furthermore, even if it were wrongly concluded in the respondent's favour that the technical teaching of the application as filed were to encompass photostability in the sense of T 116/18, it would not do so "together with the claimed subject-matter", as required by this decision.

The respondent submitted during the oral proceedings that the present case was also in line with T 1989/19 and that it was not a requirement that the application as filed disclosed improved photostability. In that case, the board held that once the criterion of the derivability of a technical effect in the sense of G 2/21 was fulfilled, this applied equally to the improvement in this effect. The board agreed with the view expressed in T 1989/19; however in the present case, photostability was not encompassed and thus not derivable from the teaching of the application as filed in the sense of G 2/21. Furthermore, unlike in T 1989/19, the application as filed in the present case referred to three polymorphic forms in equal terms, and the present case was not one in which the purported improvement was asserted to be present for the subject-matter of the application as filed over the subject-matter disclosed in the prior art.

It followed that improved photostability of Form II as demonstrated in D32 could not be taken into account in the assessment of the technical effects achieved by the distinguishing feature.